05 Apr

ANZ – Cost-Effective solutions for clinical trials

Australia and New Zealand have risen to be the go-to region to conduct clinical trials for global sponsors due to rapid study start-up timelines, high-quality data generation, proven participant recruitment and retention, and cost-effectiveness.

Clinical trials are high cost and high risk, so it makes sense to leverage the advantages of the ANZ region to successfully deliver high-quality data in a time- and cost-effective manner. 

ANZ is one of the most cost-effective regions to conduct clinical trials. Sponsors can make direct and indirect cost savings through the Australian 43.5% R&D tax rebate as well as through the rapid study start-up timelines.

PhRMA* recently estimated the average cost of a successful clinical trial in the US is between $600,00 and $8 million per day, up to $2.6 billion – this can be incredibly burdensome, especially for small to medium-sized biotechs. Australia and New Zealand are can be up to 60% cheaper than the US to conduct a clinical trial, while producing high-quality data which is accepted by the FDA or the EMA.

As discussed, the Australian R&D tax incentive is one of the factors supporting the cost-effectiveness of this region. The Australian Government offers an R&D rebate of 43.5% of clinical costs, significantly reducing the costs involved. It comes back as part of a cash rebate to eligible sponsors and for R&D costs that fit the criteria to be able to claim the rebate. 

“The AU R&D incentive is the cherry on the top of a sundae of reasons to conduct clinical trials in Australia.” – Liz Austin, Austin Legal 

The AU R&D Tax Incentive program supports Australia as an attractive region for global sponsors. Sponsors often struggle to understand the AU R&D Incentive program and an early understanding is important to ensure that appropriate structures and decisions are made. Early advice from experts, like Acclime, is a good investment for every global sponsor who may be interested in conducting a clinical trial in this region with the support of the R&D tax incentive. PharmaSols’ R&D partners, Acclime, have developed a high-level summary of information new global biotechs should consider when reviewing the AU R&D program. To learn more about the AU R&D incentive program, click here.

Another key reason why the ANZ region is more cost-effective for conducting clinical trials is the rapid study start-up times. Australia and New Zealand have streamlined ethics and regulatory processes in place, supporting the rapid start-up of a clinical trial. In addition to this, the costs associated with the regulatory submissions are relatively low compared with many other regions, such as the US and Europe. The ANZ region does not require an IND application to conduct clinical trials, saving up to a year in regulatory timelines and considerable costs for the sponsor.

At PharmaSols, we have a dedicated in-house start-up team and regulatory experts with extensive knowledge of the ethics and regulatory timeframes, providing sponsors with rapid and cost-effective solutions. By leveraging these streamlined processes and our in-house team of start-up experts, we have achieved study start-up timelines of as little as 35 days for our clients.

“Other global regions can take 6-12 months longer in the start-up phase of a clinical trial. If you think about it, every day a clinical trial is delayed costs in terms of lost revenue. That cost is often more significant than any tax rebate.” - Nicole Elliott Strategy & Finance PharmaSols.

The ANZ region gives sponsors a cost-effective solution for their clinical trials while producing high-quality data, hence becoming the go-to region to conduct clinical trials for global biotechs. 

PharmaSols is uniquely positioned in Australia and New Zealand, one of the world’s most trusted and rapidly growing clinical trial regions. With over 20 years of experience in this region, PharmaSols provides sponsors with rapid, cost-effective and high-quality clinical trial solutions. 

In addition to this, PharmaSols takes a creative problem-solving approach, has a trusted network of experts, and maintains a people-driven attitude, so you can be confident that your trial will remain on track and meet its targets.